The U.S. Food and Drug Administration has granted emergency use authorization (EAU) to a new antigen test that reportedly provides faster and more accurate results when patients are tested for the coronavirus (COVID-19).
The test is produced by Quidel Corporation and checks for virus proteins on samples collected from a patient’s nasal cavity. It reportedly has an 85 percent accuracy rating and yields results in about five minutes on machines found in most doctors’ offices.
Writing in The Wall Street Journal, former FDA Commissioner Dr. Scott Gottlieb says the test is important because it tells doctors which patients have already been infected and may now be immune to the disease.
“Whether people infected with Covid-19 develop lasting immunity hasn’t been established with certainty,” Gottlieb wrote. “But it’s clear that infection triggers a strong immune response and the production of neutralizing antibodies. There’s still a lot to learn. But if this virus behaves like others, including other coronaviruses, there’s reason to believe that these antibodies are protective at least for a year or so.”
People identified as having recovered from the coronavirus may be able to safely return to work without fear of getting sick. Other tests in development may also help doctors more accurately identify people who have the virus and quarantine them sooner.
Two types of tests
The FDA has actively fast-tracked several tests and therapeutic drugs during the pandemic. So far, it has issued emergency authorizations for two types of tests.
One type is polymerase chain reaction (PCR) tests, a molecular diagnostic testing technique that detects the genetic material from the virus and can help diagnose an active COVID-19 infection.
The second type is a serological test that looks for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to COVID-19 as part of either an active infection or a prior infection.
Faster and cheaper
The FDA says the antigen test type is relatively new and is helpful because it produces results much faster and at a much lower cost than a PRC test. It also uses the same equipment doctors employ to tell if a patient has the flu or strep throat.
“This is just the first antigen test to be authorized and we expect more to follow,” the FDA said in a statement. “We also anticipate providing an emergency use authorization template for antigen tests, similar to ones we’ve released for other test types, to help manufacturers streamline submissions and help expedite our review and issuance of additional EUAs.”
Gottlieb says this test, and others to follow, may prove to be a game-changer in how medical professionals manage the virus and return the economy to normal.